MDR Notified Body
Submit one structured request describing your medical device, class and regulatory situation — the scope can be matched with Notified Bodies designated under MDR 2017/745 with current capacity and scope covering your product.
Under MDR 2017/745, most medical devices require third-party conformity assessment by a Notified Body (NB). Self-declaration without NB involvement is permitted only for Class I devices that are not sterile, have no measuring function and are not reusable surgical instruments. Class Is, Im and Ir devices need an NB for those aspects only; Class IIa, IIb and III devices need a designated NB.
Notified Bodies under MDR are officially designated by EU Member States and listed in the Commission's NANDO database. Each NB has a specific designation scope — not every NB covers every device type, class or MDR designation code. Finding one with both current capacity and the right designation scope is the main challenge manufacturers face.
| Device Class | NB Involvement Required |
|---|---|
| Class I (non-sterile, non-measuring, not reusable surgical) | No NB — self-declaration only |
| Class I sterile or measuring function | NB for the sterility / measuring aspects only |
| Class IIa | Yes — technical documentation assessment (Annex IX/XI) |
| Class IIb | Yes — type examination or QMS audit |
| Class III | Yes — design dossier examination + QMS audit |
| Annex XVI products (no medical purpose) | Depends on class — most are Class IIa or higher and need an NB |
MDR Notified Body capacity has been severely constrained since 2021. Many NBs have waitlists, restricted scopes, or are not accepting new clients for certain device categories. Searching EUDAMED manually and contacting NBs one by one is time-consuming and often results in rejections or no response.
Designation scope is coded with the MDR codes of Implementing Regulation (EU) 2017/2185 (MDA/MDN, MDS and MDT codes) — matching your specific device to an NB with the right scope requires detailed knowledge of the designation system.
Describe your device type, classification, EMDN code and the applicable MDR designation codes, target markets and current documentation status. A prepared request can be sent to Notified Bodies that have indicated availability and whose designation scope matches your product.
You receive NB responses directly with scope confirmation, estimated timelines and next steps — without cold outreach or manual EUDAMED searches.
Send us the product details and we will tell you the next compliance step.